Pulmicort
CFC-free Inhaler 100 and 200 micrograms
budesonide
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, or you feel your asthma is getting worse, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Pulmicort CFC-free Inhaler is and what it is used for
- 2. Before you use Pulmicort CFC-free Inhaler
- 3. How to use Pulmicort CFC-free Inhaler
- 4. Possible side effects
- 5. How to store Pulmicort CFC-free Inhaler
- 6. Further information
What Pulmicort CFC-free Inhaler is and what it is used for
The name of your medicine is ‘Pulmicort CFC-free Inhaler 100 micrograms’ or ‘Pulmicort CFC-free Inhaler 200 micrograms’. However, both are referred to as ‘Pulmicort CFC-free Inhaler’ in the rest of this leaflet.
Pulmicort CFC-free Inhaler is a new inhaler which is CFC-free. It replaces Pulmicort Inhaler which contained CFC propellants.
Pulmicort CFC-free Inhaler is a pressurised inhalation suspension and contains a medicine called budesonide. Pulmicort CFC-free Inhaler 100 micrograms contains 100 micrograms budesonide per actuation. Pulmicort CFC-free Inhaler 200 micrograms contains 200 micrograms budesonide per actuation. Budesonide belongs to a group of medicines called ‘corticosteroids’ (also known as ‘steroids’). It works by reducing and preventing swelling and inflammation in your lungs.
Your doctor has prescribed this medicine to treat asthma. However, it should not be used to relieve an acute attack of asthma.
Before you use Pulmicort CFC-free Inhaler
Do not use Pulmicort CFC-free Inhaler if:
- You are allergic (hypersensitive) to budesonide or any of the other ingredients of Pulmicort CFC-free Inhaler (listed in Section 6: Further information).
Do not use Pulmicort CFC-free Inhaler if any of the above apply to you. If you are not sure, talk to your doctor, asthma nurse or pharmacist before using Pulmicort CFC-free Inhaler.
Take special care with Pulmicort CFC-free Inhaler
Before you use Pulmicort CFC-free Inhaler, tell your doctor, asthma nurse or pharmacist if:
- You have a known infection of the airways (such as a bacterial, viral or fungal infection).
- You have or have ever had tuberculosis (TB).
- You have a cold or chest infection.
- You have liver problems.
If you are not sure if any of the above apply to you, talk to your doctor, asthma nurse or pharmacist before using Pulmicort CFC-free Inhaler.
Taking other medicines
Please tell your doctor, asthma nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription, herbal medicines and any other inhalers. This is because Pulmicort CFC-free Inhaler can affect the way some medicines work and some medicines can have an effect on Pulmicort CFC-free Inhaler.
In particular, tell your doctor, asthma nurse or pharmacist if you are taking any of the following medicines:
- Other steroid medicines that you inhale, such as aerosol inhalers, powder inhalers or nebulising solutions.
- Steroid medicines that you take by mouth (such as prednisolone).
- Medicines to treat fungal infections (such as itraconazole and ketoconazole).
If you have to see another doctor or are going into hospital, make sure you take with you all of your inhalers and other medicines you have been prescribed or have bought without a prescription. If possible, these should be in the original packaging.
Pregnancy and breast-feeding
- If you are pregnant, or planning to get pregnant, talk to your doctor before using Pulmicort CFC-free Inhaler - do not use it unless your doctor tells you to.
- If you get pregnant or think you might be pregnant while using Pulmicort CFC-free Inhaler, do not stop using it but talk to your doctor immediately.
- If you are breast-feeding, talk to your doctor before using Pulmicort CFC-free Inhaler.
Driving and using machines
Pulmicort CFC-free Inhaler is not likely to affect you being able to drive or use any tools or machines.
Information you may have to carry while you are using Pulmicort CFC-free Inhaler
If you are using a high dose of Pulmicort CFC-free Inhaler your doctor may ask you to carry a steroid warning card. This explains to others about your medication.
How to use Pulmicort CFC-free Inhaler
- Always use Pulmicort CFC-free Inhaler exactly as your doctor, asthma nurse or pharmacist has told you. Ask one of them for advice if you are not sure.
- Pulmicort CFC-free Inhaler is used by breathing the medicine contained in the inhaler in through your mouth.
- Your doctor or asthma nurse will show you how to use Pulmicort CFC-free Inhaler. The instructions are given in the section below called ‘How to use your inhaler’. Carefully read them before using Pulmicort CFC-free Inhaler for the first time.
- It is important to use Pulmicort CFC-free Inhaler every day, even if you have no asthma symptoms at the time.
- Please check the label put on the inhaler by your pharmacist for further instructions on how many puffs (actuations) to take and how often to take your medicine.
- Pulmicort CFC-free Inhaler may be used with the NebuChamber spacer device. This is the only spacer device to be used with Pulmicort CFC-free Inhaler. Your NebuChamber spacer device comes with its own leaflet explaining how to use it in combination with your inhaler. If you are unsure how to use your spacer device properly please speak to your doctor, asthma nurse or pharmacist.
If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets that you take, once you start to use Pulmicort CFC-free Inhaler. If you have been taking oral steroid tablets for a long time, your doctor may want you to have blood tests from time to time. When reducing oral steroid tablets, you may feel generally unwell even though your chest symptoms may be improving. You might experience symptoms such as a stuffy or runny nose, weakness or joint or muscle pain and rash (eczema). If any of these symptoms bother you, or if symptoms such as headache, tiredness, nausea (feeling sick) or vomiting (being sick) occur, please contact your doctor immediately. You may need to take other medication if you develop allergic or arthritic symptoms. You should speak to your doctor if you are concerned as to whether you should continue to use Pulmicort CFC-free Inhaler.
Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation). Your doctor may ask you to carry a steroid warning card to explain to others about your medication.
Important information about your asthma symptoms
If you feel you are getting breathless or wheezy while using Pulmicort CFC-free Inhaler, you should continue to use it but go to see your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:
- Your breathing is getting worse or you often wake up at night with asthma.
- Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.
- You are not getting relief from your ‘reliever inhaler’ or you need more puffs than usual to control your symptoms.
- You feel your treatment is becoming less effective, or not lasting as long as it usually does.
- You have an acute asthma attack. If you have an acute asthma attack you should use your ‘reliever inhaler’ straightaway and contact your doctor immediately.
These symptoms and signs could mean that your asthma is not properly controlled and you may need different or additional treatment immediately.
Use your Pulmicort CFC-free Inhaler every day. This helps to prevent asthma symptoms.
Your doctor or asthma nurse will help you to manage your asthma. Your doctor, asthma nurse or pharmacist will advise you on how, when and how often you should use your inhaler. They will also tell you how many puffs (actuations) to take at any one time. The dose that your doctor has prescribed for you will depend on how severe your asthma is. Your doctor or asthma nurse will increase or decrease your dose as necessary. Your doctor or asthma nurse will adjust the dose of this medicine to the lowest dose that controls your asthma. Do not change the dose yourself or suddenly stop using Pulmicort CFC-free Inhaler without talking to your doctor or asthma nurse first.
The number of puffs that you need to take will depend on which strength of Pulmicort CFC-free Inhaler your doctor has prescribed.
Pulmicort CFC-free Inhaler 100 micrograms
Adults and the Elderly
- The usual dose is 2 puffs in the morning and 2 puffs in the evening.
- Your doctor may increase this up to a maximum dose of 16 puffs a day.
Children (2 to 12 years)
- The usual dose is 1 puff in the morning and 1 puff in the evening.
- Your doctor may increase this up to a maximum dose of 8 puffs a day.
The 200 microgram strength inhaler is available for children with moderately severe/severe asthma and requiring a dose of Pulmicort CFC-free Inhaler of 800 micrograms as a total daily dose. Pulmicort CFC-free Inhaler is not to be used by children less than 2 years of age.
Please turn over for dosing information for Pulmicort CFC-free Inhaler 200 micrograms.
Pulmicort CFC-free Inhaler 200 micrograms
Adults and the Elderly
- The usual dose is 1 puff in the morning and 1 puff in the evening.
- Your doctor may increase this up to a maximum dose of 8 puffs a day.
Children (2 to 12 years)
- The usual dose is 1 puff in the morning and 1 puff in the evening.
- Your doctor may increase this up to a maximum dose of 4 puffs a day.
The 100 microgram strength inhaler is available for children with mild/moderately severe asthma. Pulmicort CFC-free Inhaler is not to be used by children less than 2 years of age.
Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen.
Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Pulmicort CFC-free Inhaler to treat asthma symptoms - use your ‘reliever inhaler’.
Preparing your Pulmicort CFC-free Inhaler
Before using your new Pulmicort CFC-free Inhaler for the first time, or if you have not used your inhaler for more than 7 days, or if it has been dropped, you need to prime it for use as follows:
- Remove the dust cap from the plastic adapter. Check that the mouthpiece is clean and not blocked. Shake the inhaler vigorously, so that the contents of the aerosol canister are properly mixed.
- Press the canister twice to release two puffs into the air.
- Your inhaler is now ready for use.
How to use your inhaler
Pulmicort CFC-free Inhaler is used by breathing the medicine contained in the inhaler in through your mouth. It is important that you do not rush using your inhaler. At first, you may need to practise using the inhaler in front of the mirror. Any mist coming from the top of the inhaler or from the mouthpiece may mean that you have not inhaled the medicine properly. Young children may need help from their parents or carers to use the inhaler. Your doctor, asthma nurse or pharmacist will regularly check how you use your inhaler.
Every time you need to take an inhalation, follow the instructions below.
- 1. Remove the dust cap from the plastic adapter. Check that the mouthpiece is clean and not blocked. Shake the inhaler vigorously, so that the contents of the aerosol canister are properly mixed before each use.
- 2. Hold your Pulmicort CFC-free Inhaler upright. Breathe out as far as possible.
- 3. Place the mouthpiece between your lips. Do not breathe out through your inhaler at any time. Do not chew or bite on the mouthpiece. Start to breathe in slowly and deeply through your mouth. Keep breathing in and press the canister firmly to release a puff from your inhaler. You may need to use both hands to release a puff from your inhaler. Keep breathing in for a short while after pressing the canister.
- 4. Hold your breath for 10 seconds, or for as long as is comfortable. Hold your inhaler away from your mouth. Then breathe out slowly. If you are to take a second puff, wait at least half a minute. Then shake the inhaler vigorously and repeat steps 2, 3 and 4.
- 5. After use, replace the dust cap on the plastic adapter. Store your inhaler so that it is sitting upright on its brown plastic base.
- 6. Rinse your mouth out with water and spit it out.
Using your inhaler with a NebuChamber spacer device
- The mouthpiece of your inhaler fits directly into the NebuChamber spacer device (see the NebuChamber spacer device instruction leaflet for details on how to fit your inhaler and the NebuChamber spacer device together).
- When a small child is using the NebuChamber spacer device it is important to hold and support the spacer device in the child’s mouth and to ensure that the child breathes through the spacer device properly.
- A facemask is provided for young children who cannot breathe through the mouthpiece of the spacer device.
Cleaning your inhaler
Clean the inhaler once a week. Remove the dust cap and the aerosol canister. Clean the plastic actuator and dust cap with a dry cloth or tissue. Then replace the aerosol canister and dust cap. Do not put the inhaler into water.
If you use more Pulmicort CFC-free Inhaler than you should
If too much Pulmicort CFC-free Inhaler is used on a single occasion no harmful effects should occur. If too much Pulmicort CFC-free Inhaler is used over a long period (weeks or months) it is possible that side effects may arise. If you use more Pulmicort CFC-free Inhaler than you should, contact your doctor, asthma nurse or pharmacist for advice as soon as possible.
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You must not increase or decrease your dose without seeking medical advice.
If you forget to use Pulmicort CFC-free Inhaler
- If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose do not take the missed dose.
- Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Do not stop using this medicine without talking to your doctor.
Possible side effects
Like all medicines, Pulmicort CFC-free Inhaler can cause side effects, although not everybody gets them.
Important side effects to look out for:
- Swelling of your face, particularly around your mouth (with possible swelling of the lips, tongue, eyes and ears), rash, itching, contact dermatitis (a skin problem), hives and bronchospasm (tightening of the muscles in the airways which causes wheezing). If any of these reactions occur this may mean that you are having an allergic reaction to Pulmicort CFC-free Inhaler. You must stop using Pulmicort CFC-free Inhaler straightaway and seek medical advice immediately. This happens rarely, affecting less than 1 in 1,000 people.
- Sudden acute wheezing or shortness of breath immediately after using your inhaler. If either of these symptoms occur, stop using Pulmicort CFC-free Inhaler straightaway and use your ‘reliever’ inhaler. Contact your doctor immediately as you may need to have your treatment changed. This happens very rarely, affecting less than 1 in 10,000 people.
Other possible side effects:
Common (affects less than 1 in 10 people)
- Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your inhaler. In addition, thrush is less likely to occur if you use a NebuChamber spacer device.
- Mild sore throat, coughing and a hoarse voice.
Rare (affects less than 1 in 1,000 people)
- Feeling restless or nervous.
- Depression.
- Changes in behaviour.
- Bruising of the skin.
The following side effects may also occur, particularly if a high dose is taken for a long time, or if steroid tablets have also been prescribed or have been taken previously:
- changes in bone mineral density (thinning of the bones)
- cataract (clouding of the lens in the eye).
- glaucoma (increased pressure in the eye).
- a slowing of the rate of growth of children and adolescents. The doctor may monitor your child’s height.
- an effect on the adrenal gland (a small gland next to the kidney) causing a reduction in the hormones produced by this gland - symptoms may include headache, nausea, vomiting or feeling tired. Your doctor may ask for a blood sample from time to time to monitor the effect of the medicine on this gland. Please talk to your doctor if you want further information.
- effects which suggest too much corticosteroid in the blood (Cushing´s syndrome or Cushingoid features) - symptoms may include ‘moonface’, increased body fat and thinning of skin.
- increased likelihood of getting infections.
- inability to cope with stress, e.g. when you have a chest infection or an operation.
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious or if you notice any side effects not listed in this leaflet, or you feel your asthma is getting worse, please tell your doctor, asthma nurse or pharmacist.
How to store Pulmicort CFC-free Inhaler
- Keep out of the reach and sight of children.
- Do not store above 30°C.
- Do not remove Pulmicort CFC-free Inhaler from the outer carton until you are ready to use it. Store the carton in the position indicated.
- Always replace the dust cap after using your inhaler.
- Always store Pulmicort CFC-free Inhaler so that it is sitting upright on its brown plastic base..
- Do not use Pulmicort CFC-free Inhaler after the expiry date printed on the label and carton. The expiry date refers to the last day of that month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
Warning: The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister. The canister should not be broken, punctured or burnt, even when it seems to be empty.
Further information
What Pulmicort CFC-free Inhaler contains
The active substance is budesonide. There are two strengths of Pulmicort CFC-free Inhaler: Each metered dose of Pulmicort CFC-free Inhaler 100 micrograms contains 100 micrograms of budesonide. Each metered dose of Pulmicort CFC-free Inhaler 200 micrograms contains 200 micrograms of budesonide.
The other ingredients are norflurane (HFA 134a, a CFC-free propellant) and magnesium stearate.
What Pulmicort CFC-free Inhaler looks like and contents of the pack
Pulmicort CFC-free Inhaler is a pressurised inhalation suspension. It comes as a pressurised metered dose inhaler, which allows you to inhale the medication. Each inhaler contains 120 puffs (actuations) after the inhaler has been prepared ready for use (primed).
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Pulmicort CFC-free Inhaler are held by
Pulmicort CFC-free Inhaler is manufactured by
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Reference number
Pulmicort CFC-free Inhaler 100 micrograms: 17901/0247
Pulmicort CFC-free Inhaler 200 micrograms: 17901/0246
This is a service provided by the Royal National Institute of Blind People.
Leaflet updated: June 2009
© AstraZeneca 2009
Pulmicort is a trade mark of the AstraZeneca group of companies.
RSP 09 0025a
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